November 2024 Drug Safety Update Part 2: Meds for Prostate Cancer; Leukemia; Hereditary Angioedema; Acute Radiation Syndrome; Heparin Meds
Consumer-friendly summaries of new safety information added to Food and Drug Administration (FDA) drug labels
Cancer Treatments Safety Updates
Jylamvo (methotrexate) oral solution
Jylamvo is an oral liquid formulation of methotrexate for adults with acute lymphoblastic leukemia, severe psoriasis, Hodgkins lymphoma, and other conditions. With this label update, it is also now approved for pediatric acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen, and is also approved for polyarticular juvenile idiopathic arthritis (pJIA).
Clinical trials adverse reactions are reported. The most common adverse reactions reported in patients aged two to 18 with juvenile idiopathic arthritis:
Elevated liver tests 14%; gastrointestinal reactions (nausea, vomiting, diarrhea) 11%; stomatitis 2%; leukopenia 2%; headache 1.2%; alopecia 0.5%; dizziness 0.2%; rash 0.2%.
Most pediatric patients in the clinical trial for pJIA also received NSAIDs (such as ibuprofen) and some also received corticosteroids.
Jylamvo FDA Safety Label Change
Lysodren (mitotane)
Lysodren treats patients with adrenal gland tumors. Clinical trial data was updated to include reports of dyspnea (shortness of breath).
Also, the label now reports cardiac disorder reports of QT prolongation, which occurs when the heart muscle takes longer to contract and relax than usual. Lysodren was initially approved in 1970.
Lysodren FDA Safety Label Change
Orgovyx (relugolix)
Orgovyx lowers testosterone levels in adults with advanced prostate cancer.
Patients are warned to avoid co-administration of Orgovyx with oral P-gp inhibitors. Co-administration with a P-gp inhibitor will increase the concentration of relgolix in the blood, leading to an increased risk of adverse reactions. Examples of p-gp inhibitors include: clarithromycin, ritronivir, mifepristone, and Tamoxifen. The label provides dosage guidance if use of a p-gp inhibitor cannot be avoided.
A new drug disposal section advises patients NOT to flush the medication down the toilet and instead to use a drug-take-back location or dispose of it safely in the household trash. Orgovyx was initially approved in 2020.
The FDA has published guidance on how to dispose of unused medication: https://www.fda.gov/consumers/consumer-updates/where-and-how-dispose-unused-medicines
Orgovyx FDA Safety Label Change
Purixan (mercaptopurine)
Purixan treats acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
Two newly identified adverse reactions have been identified during post-approval use:
● Pellagra, a disease usually caused by lack of niacin, or vitamin B3. Some chemotherapy drugs are known to disrupt the body’s niacin metabolism process.
● Erythema nosum, which is a delayed hypersensitivity reaction characterized by inflamed subcutaneous fat tissue, or painful bumps on the skin.
Also, healthcare providers are advised that Purixan dosage may need adjustment when administered concomitantly with high-dose methotrexate because mercaptopurine exposure increases with concomitant methotrexate use. Purixan was initially approved in 1953.
Purixan FDA Safety Label Change
Sarclisa (satuximab-irfc) injection
Sarclisa treats adult patients with multiple myeloma (a type of leukemia)
Patients are advised that this drug can interfere with blood tests designed to match blood type for about six months after the last infusion of Sarclisa. Tell all of your healthcare providers that you are being treated with Sarclisa before receiving blood transfusions.
The label also updates clinical trial results for the incidence of second primary malignancies. Sarclisa was initially approved in 2020.
Sarclisa FDA Safety Label Change
Zarxio (filgrastim-sndz)
Zarxio boosts white blood cell counts in patients with chronic neutropenia or those undergoing chemotherapy or bone marrow transplants. Zarxio is a biosimilar (biological generic) for Neupogen (filgrastim). With the latest drug label update, Zarxio is now also approved for treating patients exposed to myelosuppressive doses of radiation, or with Acute Radiation Syndrome.
For patients receiving Zarxio because they have been suddenly (acutely) exposed to an amount of radiation that can affect bone marrow (Acute Radiation Syndrome), the Patient Information Guide was updated as follows:
The effectiveness for this use was only studied in animals, because for ethical and feasibility reasons, it could not be studied in humans.
Patients are advised that if they are receiving the drug for Acute Radiation Syndrome, they will need to have blood tests about every three days during treatment to check white blood cell counts. Zarxio was initially approved in 2015.
Zarxio FDA Safety Label Change
Heparin Drugs and Risk of Hyperkalemia (high potassium levels)
Heparin is one of the oldest and most widely used FDA-approved drugs; since 1939, it has been used as an anticoagulant for preventing and treating blood clots. Several heparin-containing drugs recently had safety label updates warning of the risk of hyperkalemia (raised levels of potassium).
Fragmin (dalteparin sodium, subcutaneous injection)
Fragmin is a “low molecular weight heparin” (LMWH) that is used for the prevention of various blood clotting conditions, including deep vein thrombosis (DVT), a type of blood clotting that usually occurs in the veins of the legs. The drug is often given before abdominal or hip replacement surgery for patients at risk of DVT.
Heparin medications can suppress the adrenal secretion of aldosterone, leading to hyperkalemia (raised levels of potassium), particularly in patients with diabetes, kidney failure, or who are taking potassium-sparing drugs. Healthcare providers are advised to measure blood potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients treated for more than five days.
Healthcare providers are advised to have patients read the FDA-approved medication guide section on the risk of hemorrhage, including spinal or epidural hematomas (abnormal pooling of blood outside a blood vessel).
Updates on pediatric clinical trials were added to the label. Fragmin is now approved to treat patients from birth (35 weeks gestational age) and up with symptomatic venous thromboembolism (VTE). VTE includes deep vein thrombosis and pulmonary embolism (blood clots in the lungs). Prior to this label change, it was approved for ages one month and up.Fragmin was initially approved in 1994.
Fragmin also has a boxed warning about the risk of spinal or epidural hematomas. Check the drug label for the complete warning.
Fragmin FDA Safety Label Change
Heparin Sodium, Liquaemin Sodium (heparin sodium) injection
Heparin Sodium, Liquaemin Sodium, and others containing heparin sodium are anticoagulants that prevent blood clots or keep them from getting worse. These medicines are administered by intravenous intravenous infusion (I.V.) or by subcutaneous injection.
Heparin medications can suppress the adrenal secretion of aldosterone, leading to hyperkalemia (raised potassium levels), particularly in patients with diabetes, kidney failure, or who are taking potassium-sparing drugs. Healthcare providers are advised to measure blood potassium in patients at risk of hyperkalemia before starting heparin therapy and periodically in all patients treated for more than five days. Heparin Sodium was initially approved in 1939.
Heparin Sodium FDA Safety Label Change
Heparin Lock Flush FDA Safety Label Change
Liquaemin Sodium FDA Safety Label Change
Liquaemin Lock Flush FDA Safety Label Change
Orladeyo (berotralstat hydrochloride)
Orladeyo prevents attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older. Hereditary angioedema is a disorder characterized by recurrent episodes of severe swelling, often affecting the limbs, face, intestinal tract, and airway.
The label was updated with post-approval reports of gastrointestinal disorders, including nausea. Orladeyo was initially approved in 2020.
Read more about the condition of hereditary angioedema at Medline Plus: https://medlineplus.gov/genetics/condition/hereditary-angioedema/
Did you miss November Drug Safety Updates Part 1? Check it out here:
Did you miss our update on over-the-counter decongestants? Check it out here:
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